Biofeedback Training for Hemianopia

NCT06995313 | Recruiting

• 1 other identifier: 20-5618
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study that compares biofeedback training on the microperimetry (BT) to a control group in patient s with hemianopia. The patients receive 5 sessions of 20 minutes to stimulate with light and sound the brain in using the best residual area on the visual fields post-brain injury visual loss. Visual tests and quality of life questionnaire are performed pre-and-post-training.

Conditions

Hemianopia; Brain Injuries

Keywords

hemianopsia; biofeedback training; brain tumor; brain trauma; visual fields; visual loss; low vision; fixation stability

Outcome Measures

Primary Outcomes (1)

• Retinal sensitivity

  Micro perimeter retinal sensitivity after performing the C 10-2 68 points test.

  Pre- intervention and 1 month post-intervention.

Secondary Outcomes (6)

• Quality of Life Self Referred Score

  Pre- intervention and 1 month post-intervention.

• Reading Speed

  Pre- intervention and 1 month post-intervention.

• Humphrey Perimetry

  Pre- intervention and 1 month post-intervention.

• Best corrected visual acuity for distance and near

  Pre- intervention and 1 month post-intervention.

• Fixation stability

  Pre- intervention and 1 month post-intervention.

Study Arms (2)

Group A

EXPERIMENTAL

This group will receive biofeedback training for 5 weeks in a row, 20 minutes. each session, on the micro perimeter.

Behavioral: Biofeedback training

Group B

NO INTERVENTION

This group will perform the same assessment tests in parallel with Group A and no intervention will be given.

Interventions

Biofeedback training BEHAVIORAL

This is an audio-luminous stimulation on the micro perimeter that teaches the brain to use a different fixation locus on the retinal other than the fovea and develops visual attention to the surrounding retinal areas. 20 minutes exercises for stimulation are performed on the micro perimeter, once a week, for 5 weeks.

Group A

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemianopia cases with more than 6 months from the date of the lesion, previously diagnosed accordingly by micro perimetry and other tests as needed, 18-90 years old, ability to follow the visual and auditory stimuli and training instructions.

You may not qualify if:

• Previous or current treatment for low vision rehabilitation, ocular diseases, other serious clinical conditions not related to the hemianopia, both eyes with media opacity that impairs microperimetry testing, lack of ability to perform the tests and training.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Hemianopsia; Brain Injuries; Brain Neoplasms; Brain Injuries, Traumatic; Vision Disorders; Vision, Low

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• MONICA Daibert Nido, Assistant

  University Healt Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Daibert-Nido, MD

CONTACT

4166035800; lowvisionuhn@gmail.com

Clarice Mediana, Assistant

CONTACT

4166035800; lowvisionuhn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The ophthalmic assistants do not have assess to the group the participant is included.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective randomized controlled clinical trial with a treated and a control group without intervention, that will occur in parallel, the control group crossing over to provide additional information.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: December 8, 2021
• Primary Completion (Estimated): July 8, 2026
• Study Completion (Estimated): July 8, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CA (1)